Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema

The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Related Lymphedema
• Intervention / Treatment: Device: digital health (Application and Smart Measuring Tape)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Republic of Korea
    • Seoul, Republic of Korea, South Korea, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between 18 and 70 years of age
• Diagnosed with breast cancer-related unilateral upper limb lymphedema
• Possessing an Android or iOS smartphone
• Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study

Exclusion Criteria:

• Diagnosed with malignant lymphedema due to metastasis or recurrence
• Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions

Discontinuation Criteria:

• Development of serious complications or cancer metastasis/recurrence during the study period
• Occurrence of a serious illness unrelated to study participation
• Failure to follow the instructions of the study physician
• Voluntary withdrawal from the study or development of circumstances preventing participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital health; Unilateral Upper Limb Lymphedema Associated with Breast Cancer	Device: digital health (Application and Smart Measuring Tape); For lymphedema management, we use a smart measuring tape to measure arm circumference and provide analysis results along with self-management strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and Acceptability	Self-Developed Questionnaire A. One item on the necessity of a lymphedema self-management app B. 23 items on satisfaction and acceptability C. Scoring scale: 1 (Strongly Disagree) - 6 (Strongly Agree)	Baseline, Month 3
SUS	Full Title: System Usability Scale A. A 10-item questionnaire to evaluate system usability B. Score range is 0-100, with a benchmark known to be 68 points Self-developed questionnaire	Baseline, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smart Measuring Tape	Upper Limb Circumference Measurement	Baseline, Month 3
TTM (Transtheoretical Model)	Objective: behavior change stage Scoring System A. Assess health behavior change on a 5-step scale B. (1) Before consideration: No intention to change problem behavior or adopt healthy behavior within the next 6 months, (2) Consideration: No specific plan but plan to take action within the next 6 months, (3) Preparation: Plan to take action within the next 30 days, (4) Action: In progress (less than 6 months), (5) Maintenance: In progress (more than 6 months) C. Check whether the change in the stage has occurred in a positive direction	Baseline, Month 3
LYMQOL	Full Title: Lymphedema quality of life questionnaire A. A questionnaire to measure the quality of life in patients with arm lymphedema B. Composed of subdomains including function, appearance, symptoms, mood, and quality of life C. Function, appearance, symptoms, and mood are rated on a 1-4 scale where lower scores indicate better quality of life, while quality of life is rated on a 0-10 scale where higher scores indicate better quality of life	Baseline, Month 3
EQ-5D-5L	Full Title: EuroQol 5-Dimension 5-level Objective: quality of life Scoring System: Each item is evaluated on a 5-point scale and weighted according to the country. EQ VAS evaluates data on a scale of 0-100, with a higher score indicating better health.	Baseline, Month 3
self-efficacy	Full Title: lymphedema-specific exercise barriers self-efficacy A. Composed of 9 general exercise barriers and 5 lymphedema-related barrier items B. Evaluates how confident one feels about exercising in each situation on a scale from 0% (not confident at all) to 100% (extremely confident) with 10% intervals C. Interpreted as '0-20%=not confident at all, 20-40%=slightly confident, 40-60%=moderately confident, 60-80%=very confident, 80-100%=extremely confident'	Baseline, Month 3
upper arm use	Self-developed questionnaire A. Level of self-awareness of edema, amount of affected arm use, anxiety about using the affected arm B. Level of self-awareness of edema: 2 items, 0 (not at all) - 10 (very much) scale C. Amount of affected arm use: 1 item, change in arm usage on a -5 to 5 scale D. Anxiety about using the affected arm: 1 item, change in anxiety about arm use on a -5 to 5 scale	Baseline, Month 3
ICF (International Classification of Functioning, Disability, and Health)	Objective: function, activity and participant, environment Scoring System: A. Assess the 8 items of body functions, 8 items of activities and participation, and 8 items of environmental factors of the breast cancer ICF core set brief B. Body functions are assessed as 0 (no problems) - 4 (extreme problems), 9 (not applicable). Activities and participation are assessed as 0 (no difficulties) - 4 (extreme difficulties), 9 (not applicable). Environment is assessed as 0 (no barriers) - 4 (extreme barriers), +0 (no facilitating factors) - +4 (complete facilitating factors), 9 (not applicable).	Baseline, Month 3
COPM	Full Title: Canadian Occupational Performance Measure A. A client-centered assessment that identifies and prioritizes everyday problems that limit an individual's participation in daily life across all areas, including self-management, productive activities, and leisure B. Performance and satisfaction for activities selected as important issues are evaluated on a 0-10 scale C. Clinically significant change = 2-point change	Baseline, Month 3
Perometer	Optoelectronic Limb Volumeter (Perometer) Upper Limb Volume Measurement	Baseline, Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GPAQ	Full Title: Global Physical Activity Questionnaire Consists of 16 questions designed to estimate an individual's physical activity level and sedentary time across three domains (work, transportation, and leisure time)	Baseline

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Actual): October 21, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema
• Other Study ID Numbers: SMC 2024-04-011; HA23C0423 (Other Identifier: National Cancer Center (NCC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No